Digital Sleep Program for College Students with Insomnia

ConditionInsomnia

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-26

SponsorTaipei Medical University

About this trial

This randomized controlled trial (RCT) study aims to evaluate the effectiveness of a digital-based multimodal sleep management program compared to a waitlist control group in improving sleep-related outcomes, including insomnia severity, daytime sleepiness, objective sleep parameters, and sleep reactivity to stress, as well as psychological health indices, such as depression, anxiety, and resilience. Additionally, this study seeks to examine the mediating role of different chronotypes in the effectiveness of the sleep intervention on the outcomes of interest.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Registered as a full-time student

Aged 18 to 26 years old

Experiencing insomnia for at least three months

Currently own and use a personal mobile device

Disqualifiers

Using a smartphone model that cannot support the app

Currently using other sleep program apps

Meeting a STOP-BANG score of ≥3

Trial design

Design model

Parallel

Treatments tested in this trial

Waitlist control group
Other intervention
The participants in the waitlist control group will be informed that they are on a waiting list during the intervention period, serving as a no-treatment control. They will receive the sleep intervention (i.e., the digital-based sleep management program) four weeks after the intervention period is completed.
digital-based multimodal sleep management program
Behavioral
The digital-based multimodal sleep management program consists of (1) sleep hygiene education, (2) sleep restriction, and (3) mindfulness breathing exercises. The program is internet-integrated and delivered via Google Meet, with 45-minute weekly sessions over four weeks. To increase participants' adherence to the sleep management program , the course instructor will request the participants to record their daily sleep diaries (time to bed, time to sleep, wake time during sleep and wake time) and sleep journals(practices of sleep hygiene, sleep restriction and mindfulness breathing exercise) in the mobile app for at least five consecutive days each week.

Treatment groups

90 Participants

are divided into 2 treatment groups

Group A: Waitlist control groupOther 1 intervention

Group B: digital-based multimodal sleep management programExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Insomnia Severity:The Insomnia Severity Index (ISI)

The Insomnia Severity Index (ISI) consists of seven items that assess the current perception of the severity of three insomnia symptoms. Each item is rated on a 5-point Likert scale, with the total score ranging from 0 to 28. Higher scores indicate greater severity of insomnia.

Time frame

T0 = baseline; T1 = immediately after intervention; T2 = 4 weeks after intervention.

Secondary outcomes

Daytime Sleepiness:The Epworth Sleepiness Scale (ESS)

The Epworth Sleepiness Scale (ESS) is a self-reported measure of daytime sleepiness, assessing the propensity to doze or fall asleep during eight common daily activities. Each situation is rated on a 4-point scale, ranging from 0 ("would never doze") to 3 ("high chance of dozing"). The total score, obtained by summing the scores of the eight items, ranges from 0 to 24, with higher scores indicating greater levels of daytime sleepiness.

Time frame

T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention.

Sleep Parameters

The sleep parameters will be recorded using a wearable sleep tracker (oCare Wrist-Worn Pro 100, Taiwan Biophotonic Corporation, Taiwan) daily for five consecutive days both before and immediately after the intervention. The wearable device will be paired with a mobile app for data collection and analysis. The sleep parameters derived from the device include sleep onset latency (SOL), wake after sleep onset (WASO), time in bed (TIB), total sleep time (TST), and sleep efficiency (SE).

Time frame

T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention

Sleep Reactivity: The Chinese version of the Ford Insomnia Response to Stress Test (FIRST)

The Ford Insomnia Response to Stress Test (FIRST) measures the extent to which sleep is affected by stress in individuals experiencing stressful conditions. It is a self-administered questionnaire consisting of nine questions, each rated on a 4-point scale, ranging from 1 (unlikely to happen) to 4 (very likely to happen). The total score ranges from 9 to 36, with higher scores indicating a greater degree of sleep disruption due to stress.

Time frame

T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention

Resilience: The Chinese version of the Brief Resilience Scale (BRS)

The Brief Resilience Scale (BRS) consists of six questions, each rated on a 5-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree). Questions 1, 3, and 5 are forward-scored, while questions 2, 4, and 6 are reverse-scored. The total score ranges from 5 to 25, with higher scores indicating greater resilience, reflecting an individual's ability to adapt and recover from adverse events.

Time frame

T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention

Other outcomes

Chronotype: The Chinese version of the Morningness-Eveningness Questionnaire (MEQ)

The Morningness-Eveningness Questionnaire (MEQ) is a self-administered questionnaire consisting of 19 questions that assess an individual's preferred bedtime, wake-up time, and activity time. Responses are scored on a Likert-type scale, with total scores ranging from 16 to 86, reflecting differences in circadian rhythms. Higher scores indicate a stronger tendency to be a morning-type individual.

Time frame

T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Taipei Medical University

Lead sponsor

National Science and Technology Council, Taiwan

Collaborator

Source ClinicalTrials.gov

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